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DockTales for Chronic Pain

2. september 2026 oppdatert av: University of Maryland, Baltimore

Evaluating Feasibility and Acceptability of DockTales for Chronic Pain

This study will evaluate the feasibility and acceptability of DockTales, a mobile health tool designed for adults with chronic pain. DockTales supports pain and sleep tracking through brief diaries, body-map pain reporting, reflective journaling, visual summaries, and optional AI-supported interaction. The study will be conducted completely remotely. Participants will complete 2 weeks of DockTales use and 2 weeks of REDCap-based daily monitoring, with the order randomized. The main goal is to determine whether DockTales is usable, acceptable, engaging, and practical for adults with chronic pain compared with standard REDCap monitoring.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a fully remote, randomized crossover pilot clinical trial designed to evaluate the feasibility and acceptability of DockTales among adults with chronic pain. Chronic pain is defined as pain lasting for more than 3 months. A total of up to 60 participants will be enrolled.

Participants will be randomized in a 1:1 ratio to one of two study sequences. Participants assigned to Sequence 1 will complete 2 weeks of DockTales use followed by 2 weeks of REDCap-based daily monitoring. Participants assigned to Sequence 2 will complete 2 weeks of REDCap-based daily monitoring followed by 2 weeks of DockTales use. All participants will complete both study conditions.

Participants will complete questionnaires at baseline, after the first 2-week period, and after the second 2-week period. These assessments will evaluate feasibility, acceptability, usability, burden, engagement, technical issues, participant preference, and exploratory pain and sleep-related outcomes. Some participants may also complete an optional remote semi-structured interview after finishing both study conditions.

The primary outcomes are feasibility and acceptability. Feasibility will be assessed through recruitment, retention, adherence, completion of DockTales use, completion of REDCap monitoring, missing data, and technical issues. Acceptability will be assessed through satisfaction, engagement, perceived usefulness, ease of use, burden, willingness to use DockTales again, and preference between DockTales and REDCap monitoring.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland Baltimore School of Nursing
        • Hovedetterforsker:
          • Yang Wang, PhD
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age ( 18-88 years old)
  • English speaker (written and spoken)
  • Chronic pain for at least 3 months
  • Smartphone/text messaging capability

Exclusion Criteria:

  • Any personal history of mania, schizophrenia, or other psychoses
  • Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
  • Pregnancy or breast feeding
  • Impaired or uncorrected hearing

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: DockTales first
This is a crossover-designed study with one arm of chronic pain participants. All participants will complete both active (DockTales) and control (REDCap) interventions in a randomized sequence. The first arm will complete 2 weeks of DockTales first, and 2 weeks of REDCap monitoring
Atferdsmessig: DockTales

DockTales includes several core features:

  1. Brief diary entries
  2. Body-map pain reporting/feedback
  3. Reflective journaling
  4. Optional AI-supported interaction The AI-supported feature is not intended to provide medical advice, diagnosis, treatment recommendations, mental health care, or emergency support.

The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.

Annen: REDCap monitoring
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
Annen: REDCap first
This is a crossover-designed study. Participants in this arm will start with 2 weeks of REDCap monitoring, followed by 2 weeks of DockTales use
Atferdsmessig: DockTales

DockTales includes several core features:

  1. Brief diary entries
  2. Body-map pain reporting/feedback
  3. Reflective journaling
  4. Optional AI-supported interaction The AI-supported feature is not intended to provide medical advice, diagnosis, treatment recommendations, mental health care, or emergency support.

The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.

Annen: REDCap monitoring
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Enrollment rate
Tidsramme: At the enrollment
Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
At the enrollment
Retention rate
Tidsramme: End of Week 4
Retention rate: the proportion (%) of enrolled participants who finished the study
End of Week 4
Module completion rate
Tidsramme: End of Week 4
Module rate: the proportion (%) of completed modules in the DockTales app. The DockTales app contains 1) daily monitoring module; 2) navigation map module; 3) AI avatar companion module; and 4) daily dairy module.
End of Week 4
Daily survey completion rate
Tidsramme: End of Week 4
Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
End of Week 4
Levels of satisfaction
Tidsramme: End of Week 2 and Week 4
Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied.
End of Week 2 and Week 4
Levels of enjoyment
Tidsramme: End of Week 2 and Week 4
Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed.
End of Week 2 and Week 4
Levels of engagement
Tidsramme: End of Week 2 and Week 4
Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged.
End of Week 2 and Week 4

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Maryland, Baltimore

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

17. juli 2027

Primær fullføring (Antatt)

17. juli 2028

Studiet fullført (Antatt)

24. oktober 2029

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

25. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HP-00119506

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

The study team has not yet determined whether individual participant data will be shared. This pilot study will collect sensitive health-related data and DockTales free-text interaction data, which may inadvertently include identifiable information. Any future sharing would be limited to de-identified data, would exclude direct identifiers and raw free-text data unless appropriately redacted, and would occur only after IRB approval and in accordance with institutional policies.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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